Optimal Location of Local Anesthetic Injection for Ultrasound Guided Interscalene Block

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01877330
First received: December 12, 2012
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

This is a prospective randomized clinical trial to determine where is the optimal location for local anesthetic injection for ultrasound guided interscalene nerve blocks. The investigators are investigating if local anesthetic deposited between the nerve roots is more effective than local anesthetic deposited in the interscalene groove.


Condition Intervention
Shoulder Arthroscopy
Ultrasound-guided Interscalene Nerve Block
Procedure: Interscalene block for shoulder arthroscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraplexus vs Extraplexus Injection of Local Anesthetic for Interscalene Block for Patients Undergoing Arthroscopic Shoulder Surgery

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Onset of motor blockade [ Time Frame: 1 hour from time of injection ] [ Designated as safety issue: No ]
    Time to loss of shoulder abduction.


Secondary Outcome Measures:
  • Patient Satisfaction Score [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Opioid consumption [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Opioid consumption - perioperative and post discharge

  • Quality of Nerve block [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    onset of sensory block

  • Incidence of post-operative nausea/vomiting [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Duration of nerve block [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Duration of analgesia from nerve block

  • Number of needle passes [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • Number of paresthesias [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
    number of paresthesia experience during nerve block

  • Residual paresthesia [ Time Frame: 24 hour ] [ Designated as safety issue: Yes ]
    incidence of residual paresthesias


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Injection in interscalene groove
Patients undergoing shoulder arthroscopy will have an interscalene nerve block by injection of ropivacaine in the interscalene groove anterior and posterior to the brachial plexus nerves.
Procedure: Interscalene block for shoulder arthroscopy
Active Comparator: Injection between nerve roots
Patients undergoing shoulder arthroscopy will have an interscalene nerve block by injection of ropivacaine in the interscalene groove inbetween the C5 and C6 nerve roots.
Procedure: Interscalene block for shoulder arthroscopy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

ASA I-II patients who are 18 years and older and who are scheduled for shoulder arthroscopy are eligible for enrollment provided they do not have any of the following exclusion criteria.

Exclusion Criteria:

  • chronic pain
  • high preoperative opioid requirement
  • age < 18 years old
  • non-English speaking
  • contraindication to regional anesthesia (allergy to local anesthetics, coagulopathy, severe thrombocytopenia, pre-existing neuropathy in operative limb, infection at puncture site)
  • need for postoperative nerve function monitoring
  • patient refusal
  • dementia
  • pulmonary disease or low baseline oxygen saturation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01877330

Contacts
Contact: Pedram Aleshi, MD (415) 476-8964 aleship@anesthesia.ucsf.edu
Contact: Monica W Harbell, MD (415) 476-8964 harbellm@anesthesia.ucsf.edu415-

Locations
United States, California
UCSF Orthopedic Institute Recruiting
San Francisco, California, United States, 94158
Principal Investigator: Pedram Aleshi, MD         
Principal Investigator: Monica Harbell, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Pedram Aleshi, MD University of California, San Francisco
Principal Investigator: Monica W Harbell, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01877330     History of Changes
Other Study ID Numbers: ISNB001
Study First Received: December 12, 2012
Last Updated: June 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
shoulder arthroscopy
ultrasound guided nerve block
interscalene nerve block

Additional relevant MeSH terms:
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014